For decades urinary incontinence or incontinency has been associated with shame, embarrassment and silence even though the World Health Organization estimates that there are 200 million worldwide with symptoms of male or female urinary incontinence. A true number is not known because the problem is so under reported. It is estimated that urinary incontinence affects 25 million Americans. This condition impacts quality of life by interfering with work, travel, social recreation and is associated with an increased number of falls, urinary tract infections and skin breakdown. Professionals are only recently learning progressive therapies for incontinence and many lay persons are still keeping their problem a secret. Prevention of this problem is a relatively new concept with little research data reported. Factors involved in bladder and/or sphincter problems and pelvic support are being looked at for preventing some forms of urinary incontinence.
Various devices have been disclosed in the patent literature attempting to address the problems of female urinary incontinence. For example, U.S. Pat. No. 3,335,714 discloses a device which concentrates on taking a sample of urine, but not a device intended for extended use. A portion of the xe2x80x9csealxe2x80x9d area extends into a portion of the vagina for sealing purposes, but not for positioning purposes. A vent is not included in the device to enhance free-flow.
U.S. Pat. No. 3,512,185 discloses a device which covers both the vagina and the urethra areas with flexible shoulders to assist retention by the labia. The vagina is not used for positioning purposes.
U.S. Pat. No. 4,198,979 discloses a device using an adhesive to form a non-vented cavity that encompasses both the vagina and urethra. The device seal is designed to catch the body fluids of both the vagina and urethra. A portion of the seal enters the vagina to effect a complete adhesive seal. The device does not use the vagina for positioning or does not use a venting method. Entry into the vagina is for sealing only.
U.S. Pat. No. 4,496,355 discloses a device that collects urine via a sealing cup extending around the urethra and held in place by the labia. The seal area is xe2x80x9cbetweenxe2x80x9d the vagina and the urethra. No mention is made of using the vagina for positioning purposes or venting the cavity that collects the urine.
U.S. Pat. No. 4,568,339 discloses a device using a groove into which an adhesive can be retained for xe2x80x9cleak-freexe2x80x9d fit around the urethra. The vagina cavity is not used.
U.S. Pat. No. 4,787,654 discloses a device which is designed to create a vacuum seal in a cup that surrounds the urethra. A vent is located in the line to allow urine to flow into the bag, but maintains a vacuum seal aided by the labia. The device makes no use of the vagina nor of a cup vent.
U.S. Pat. No. 4,795,449 discloses a form-fitting device using an adhesive surface for a leak-free cup. No mention is made of venting or of vagina positioning.
U.S. Pat. No. 4,846,819 discloses a device that uses a conformable gel to effect a complete xe2x80x9cleak-freexe2x80x9d seal around the urethra area. No mention is made of a vagina bulb or of a method of venting for free-flow of urine.
U.S. Pat. No. 4,904,248 discloses a device using an adhesive to effect a xe2x80x9cleak-freexe2x80x9d urethra cup that is vented in the tube area near the receptacle bag. The patent does not disclose the use of the vagina in any way, nor is the cup vented. Venting in the bag tubing will not effect free-flow from the device.
U.S. Pat. No. 6,342,049 discloses a device which is designed to use an xe2x80x9cOxe2x80x9d ring type of seal to effect a xe2x80x9cleak-proofxe2x80x9d seal around the urethra which does not include the vagina. A small lip on the sealing ring may be used to locate the seal by pressing on a portion of the vagina wall. No mention is made of venting the cup volume, because the device is designed for female astronauts.
A female urinary system includes an appliance, a portion of which is a hollow open top body having a peripheral rim for fitting under the urethra so that urine may flow into the body. The body has an outlet passage for discharging the urine into a collection bag. The appliance also includes a vaginal locating bulb extending posteriorly of the body. The bulb has an outer surface with a contact portion for fitting against the labia minora at the vestibule outwardly of the vagina. At least one longitudinal groove, and preferably a plurality of grooves, is provided on the posterior portion of the outer surface of the bulb. The grooves intersect the contact portion and extend downwardly for permitting the flow of fluid outwardly from the vagina when the locating bulb is mounted in place. Preferably, a vent extends from the hollow body through the appliance at the bulb to function as a vacuum break.
The portion of the bulb which is posterior of the hollow body is generally of oblong ball shape having a curved upper surface upwardly of the contact portion. The upper surface extends into the vestibule, but is spaced from the vagina. The hollow body is preferably in the shape of a discharge bowl which has a drain extension at its lower portion to function as the outlet passage. The interior of the bowl is tapered toward the extension so that the urine would flow into the extension. Preferably, the bulb and body are of one piece integral construction formed of a soft conformable material. A rim at the upper end of the body is preferably radially outwardly extending to permit the labia to fold around the rim at the seal area.